MAUDE Adverse Event Report: SEASPINE, INC MARINER PEDICLE SCREW SYSTEM; SCREW SET

Device Problems Fracture (1260); Material Fragmentation (1261)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Event Description

Screw fracture 6 weeks post-op with no reported patient trauma.Images provided.Facility not indicated at time of report.Images were provided that show before and after fracture.Images attached.

Manufacturer Narrative

The report of a screw fracture was reported on (b)(6) 2022.There was no information on whether there would be a revision at the time of this report.Subsequent follow up was not able to obtain additional information.Review of labeling: possible adverse events: loosening of spinal fixation implants may occur due to, latent infection, and/or premature loading, possibly resulting in bone erosion, migration or pain.

• Brand Name: MARINER PEDICLE SCREW SYSTEM
• Type of Device: SCREW SET
• Manufacturer (Section D): SEASPINE, INC; 5770 armada drive; carlsbad CA 92008
• Manufacturer (Section G): SEASPINE, INC.; 5770 armada drive; carlsbad CA 92008
• Manufacturer Contact: taara maharaj ; 5770 armada dr.; carlsbad, CA 92008 ; 7602165150
• MDR Report Key: 13810017
• MDR Text Key: 287416832
• Report Number: 3012120772-2022-00007
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other